Expert opinion on pharmacotherapy
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Expert Opin Pharmacother · Jan 2015
Randomized Controlled Trial Multicenter StudyA multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain.
This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP). ⋯ HYD was shown to be an efficacious treatment for CLBP in this study. There were no new or unexpected safety concerns detected.